CAR-T

Fresh turmoil inside Novartis’ revamped CAR-T organization as top exec jumps ship


There’s more turmoil to report from inside Novartis’ CAR-T camp.

On Friday Karen Walker will leave a senior position in charge of CMC/manufacturing of CAR-Ts for Novartis in exchange for a new position she’s taking at Seattle Genetics, Endpoints News has learned.

Walker — the VP Global Head Cell and Gene Therapies Technical Development and Manufacturing at Novartis — was one of three senior execs put in charge of the cell and gene therapy initiative at the company last fall, according to sources close to the company, after a bruising restructuring over the summer in which the unit was chopped up and absorbed inside a huge R&D organization. Samuele Butera was put in charge of the commercial/business aspect of the group while David Lebwohl handles clinical ops.

“Karen Walker will join Seattle Genetics as Vice President of Global Quality in mid-April,” confirmed a spokesperson for Seattle Genetics.

I contacted Eric Althoff, a spokesperson for Novartis, Wednesday night, but after acknowledging my query he did not follow up. Althoff has declined to respond to a followup query.

Novartis has been bleeding talent throughout its global organization for the past year. Walker’s departure, though, comes at a particularly critical stage for Novartis, just days after the pharma giant gained a priority review for CTL019, putting it on a short path to perhaps the first historic approval for a CAR-T.

Last summer Endpoints broke the story about Novartis’ reorganization in CAR-T, which led the group’s top exec, Usman ‘Oz’ Azam, to leave Novartis. About 120 staffers were also terminated as the separate group was pulled back into the R&D structure.

Novartis has kept up a neck-and-neck race with Kite on the lead program, which has its own pioneering CAR-T headed to the FDA.

Manufacturing in this field is critical. To make this therapy, physicians extracts cells from cancer patients and then reengineer them with a chimeric antigen receptor to guide them to attack cancer cells. The revised cells are then injected back into patients. To be competitive, a company has to prove not only that they know how to make the therapy, they also have to be able to turn it around quickly for use.



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Biomanufacturing